Objective: To study the definition of the potency unit of the anticoagulant activity of leech, and to investigate the method of assigning values according to the definition and the applicability of the reference materials. Methods: The unit of anticoagulant potency was theoretically designed as follows: at 50 μL added 20 μL to rabbit plasma in the proportion of leech solution, the partial activated prothrombin time (APTT) of rabbit blank plasma was prolonged by 0.5 times, and the amount required in 1 mL plasma was a titer unit. Under this definition, the formula for calculating the potency assignment by using the concentration APTT measured value could be deduced. Then, five laboratories were combined to determine and count the assignment of the control medicinal materials of leech and phenanthrene leech, and the applicability of the assignment results to the medicinal materials and preparations was investigated. Results: According to the unified standard operating procedures, the five laboratories could use the formula defined by potency, and use the extension value of APTT to determine the anticoagulant activity of leech control and phenanthrene ox leech control. According to statistics, the value of leech control was 325 units per 1 g, and the value of phenanthrene ox leech control was 295 units per 1 g. After assignment, the two reference materials were applicable to the determination of anticoagulant activity of leech, Japanese medical leech and preparations respectively. Conclusion: The definition of anticoagulant potency of leech is scientific and reasonable. It can be assigned by experiments. The assignment is applicable to both medicinal materials and preparations.
HU Yu-chi, XIAO Si-ting, YANG Wen-liang, GUO Yu-dong, XU Hua-yu, LI Bo, GAO Hua, ZHANG Yuan, TANG Li-ming, ZHANG Su-hui, PIAO Jin-hua, WANG Ting-ting, ZHANG Hong, RUI Jing, HUA Xiao-dong, HOU Juan, YANG Tian-jiao
. Study on the definition of anticoagulant activity potency unit of leeches and the value assignment of reference medicinal materials*[J]. Chinese Journal of Pharmaceutical Analysis, 2023
, 43(5)
: 837
-848
.
DOI: 10.16155/j.0254-1793.2023.05.14
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